Assessing and Building Readiness

Assessing Resources

Each organization that decides to initiate a PC-CIS will want to assess its readiness for undertaking this effort. For assistance in assessing readiness, there are tools and checklists developed by groups working on similar efforts. Examples include:

  • Stakeholder Engagement in Research Studies Toolkit
  • Toolkit on Patient Partner Engagement in Research (HIPXChange TOPPER) Toolkit
  • Partnership and Infrastructure to Support Patient & Stakeholder Engagement: A Scan of PCORnet Practices
  • Patient-Focused Medicines Development’s (PFMD) Patient Engagement Management (PEM) Suite includes several resources including these How-To Guides

Another important readiness measure is preventing duplication of efforts or “right hand/left hand” confusion, particularly within large organizations or companies. Anyone preparing to pursue the creation of a PC-CIS should take stock of the entirety of the organization or company, and identify any potential individuals, teams, or departments that may own or have institutional knowledge of relevant information or relevant data that can be useful.

Interim Deliverables

Each step laid out in this Blueprint is intentional and important to completing development of a sound PC-CIS. However, a group working toward a PC-CIS may not be able to complete the entire effort as a single project. There are not any elements of PC-CIS development that can be skipped.

However, it is possible to think about PC-CIS development as an incremental process with a series of separate deliverables that can be valuable and useful on their own.  Examples of these interim deliverables are outlined below. (Note that each of these interim deliverables are described in more detail in the related sections of the blueprint.)

Set of impacts complied from existing data on patient experiences (evaluated for qualiy and relevance)

Set of impacts compiled through primary data collection from patients

Set of patient-priotitized impacts

Set of impacts compiled from existing other-stakeholder data (evaluated for quality and relevance)

Set of impacts compiled through primary data collected from other stakeholders

Combined set of impacts from patients and other stakeholders

Budget Development and Financing

For guidance in creating a budget and determining compensation and support for various project partners, see:

  • De-identified Budget from a U.S. Food and Drug Administration (FDA) Patient-Focused Drug Development (PFDD) project
  • De-identified Budget from a Patient-Centered Outcomes Research Institute (PCORI) Engagement Award
  • The Improve Care Now sponsorship page reflects the wide array of potential funders for such work including individual donors, banks, foundations, and federal partners.
  • The National Health Council (NHC) Compensation Principles (for US compensation) and Fair-Market Value (FMV) calculator for compensating US patients and patient advocacy groups
  • PCORI Framework for Compensation
  • The PFMD’s Patient Engagement Remuneration and Fair Market Value tool for non-US compensation

Areas to consider when developing a budget include:


Types of Activities

Patient group staff time (or consultants)

Project management

Event planning (virtual and in-person gatherings)

Secondary data collection

Primary data collection

Data analysis

Data assembly

Documentation of methods

Report preparation


Meeting and conference costs (virtual or in-person)

Zoom, WebEx, or similar tools for large, interactive virtual meetings

Meeting room space, travel costs for in-person meetings

Recording and transcription costs (virtual or in-person)

Food, drink, hotel, and other in-person meeting costs


Patient and expert partners

Research participants

Research expenses

Secondary data purchase costs

Primary data collection (e.g., consultants, academic partners)

The cost of publishing open-source publications

Other vendors


Graphic design

Health literacy


Sources of Support

Clearly, most organizations will not have all the financial resources to undertake PC-CIS development. Patient organizations must find ways to leverage what they have in-house in terms of staffing, data, and expertise, and will also need to seek funds such as grants and in-kind support. A patient group can begin by working with the partners they identify in the consortium to determine what each partner can bring to the table. To fill financial and resource gaps, the group can seek grants and  support from organizations such as the Patient-Centered Outcomes Research Institute (PCORI), life-science companies interested in the disease area, or local or national health foundations.

Funding and Conflict of Interest

Important to the consideration of any funding source is maintaining independence and clear boundaries. In any fundraising efforts, it is valuable to consider any real or the appearance of conflicts of interest or undue influence.  The National Health Council has a set of Standards of Excellence for patient groups that includes guidance for appropriately considering and disclosing funding from industry sources.

Resources to help here include:

Training and Onboarding

For any multi-stakeholder endeavor, but particularly efforts that prioritize and depend upon the role of patients, training or onboarding is an incredibly valuable tool for all stakeholders.  Training can be valuable for familiarizing patients with research methodology, regulatory processes, or other concepts. Training is also key is for clinicians, researchers, and other stakeholders who may not have had experiences partnering with patients in such efforts. A number of existing trainings is available depending on the context of your PC-CIS development work.  A sampling includes:

  • Patient-Centered Outcomes Research Institute (PCORI) Research Fundamentals Training
  • Multi-Method Patient-Engagement Approach: A Case Example from a PCORI-Funded Training Project
  • The Kaiser Foundation Patient Engagement Toolkit and Guidance for training and engaging patients in data analysis
  • HIPxChange Deeply Engaging Patients with a Mix & Match of Methods
  • Patient-Focused Medicines Development’s (PFMD) Patient Engagement Management (PEM) Engagement Training

Depending on the community or group that is leading or being invited to partner in PC-CIS development, this training and onboarding step may need to come early in the planning process — potentially, as a very first step.  Providing foundational training on engagement principles and the landscape of patients serving as partners in research, policy, and elsewhere in health care innovation may be an important “onramp” to PC-CIS creation for those very new to this type of activity.

Arthritis Use Case

For the INSIGHTS program, early considerations were technical and functional:

  • Who would own the data?
  • What would maintenance and upkeep cost?
  • Would the Health Insurance Portability and Accountability Act (HIPAA) be triggered in any way?
  • How often should patient-reported outcome surveys be done?
  • How often should analysis and data go to end-users?

In terms of resources, this was a significant commitment and investment from the Arthritis Foundation (AF).  The opportunity to develop and maintain the program was a key element of fundraising efforts both from individual, and corporate donors and sponsors.